IPEC: Risk Assessment Guide for Excipients now available
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The new version 1 of the "IPEC Risk Assessment Guide for Pharmaceutical Excipients - Risk Assessment for Excipient Manufacturers (Version 1, 2025)" has just been published on the website of the IPEC (International Pharmaceutical Excipients Council Europe (IPEC Europe)). This guide has been available to IPEC members in the members' area since May 2025 only and can now be accessed under "Resources" in the "Guidelines" section.
The table of contents of version 1 of the new guide published in 2025 includes the following chapters, with chapters 1, 2, and 4 containing further subchapters and subsections. This is an overview of the main chapters:
ACKNOWLEDGEMENTS
1 INTRODUCTION
2 PRINCIPLES OF RISK ASSESSMENT AND MANAGEMENT
3 RISK ASSESSMENT METHODS
4 RISK ASSESSMENT BY EXCIPIENT MANUFACTURER
5 REFERENCES
The full version 1 of the "IPEC Risk Assessment Guide for Pharmaceutical Excipients - Risk Assessment for Excipient Manufacturers (Version 1, 2025)" can be found on the IPEC website.
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